EP3200709B1

Movatterモバイル変換

Info

Publication number: EP3200709B1
Application number: EP15779129.4A
Authority: EP
Inventors: Roy W. Sanders; Sergio Gutierrez
Original assignee: Foot Innovations LLC
Current assignee: Foot Innovations LLC
Priority date: 2014-10-01
Filing date: 2015-09-30
Publication date: 2020-06-24
Anticipated expiration: 2035-09-30
Also published as: US20210378711A1; US20160095626A1; US9597116B2; WO2016054262A3; US20160095624A1; US11096722B2; US9597117B2; US9427259B2; EP3795102A1; US20170245893A1; WO2016054262A2; EP3200709A2; EP3795102B1; US20200054359A1; US20160095625A1; EP3795102C0; US10357285B2

Description

TECHNICAL FIELD

The present disclosure relates generally to fracture fixation systems, methods, and components. More particularly, the disclosure relates to improved anatomic external fixation systems, methods, and components. Particular embodiments described herein can be used to set bone fragments in long bone fractures (e.g., tibia fractures, femur fractures, fibula fractures, etc...).

BACKGROUND

External fixation devices have been widely used in the treatment of long bone fractures and are best suited in cases of unstable, comminuted fractures. An example of this would be a compound fracture of the tibia that would generally be fixed with a cast. If the fracture is too comminuted, the cast will be unable to provide enough support to the fragments, thus leading to a malunion or a nonunion. The external fixation device helps stabilize the bone fragments and allow the patient a quicker recovery time with fewer complications.
Current external fixation devices consist of straight rods and ring-frames made of carbon fiber that can be interconnected through the use of clamps. The clamps can be two sided with one side clamping to the straight bar and the other side clamping to a bone pin that is fixed to a bone or bone fragment. These two clamps are connected to each other via a ball joint that allows for some adjustability, thus allowing various angles in between the rods and the pins. Once the surgeon has adjusted the rods and pins to the desired positions, they have to lock everything in place by tightening nuts on each side of the clamp. The process of locking each clamp in place can be cumbersome and may require multiple assistants to aid in the procedure. This adds complexity and wastes valuable resources.
External fixator devices with hinges for fixing injury around joints such as the elbow, the knee, and the ankle are generally designed for use only on the right side or only on the left side of the joint or limb. These hinged systems must be mounted on the bone with the mechanical pivot axis of the device aligned with the natural pivot axis of the joint. These designed limitations not only demand that hospitals dedicate a large inventory for accommodating high volume of external fixator devices, but also increase surgical time and complexity in installing the devices on patients.
Italian patent application publication102012902071180 A1 discloses a clamping device comprising a clamp body and a locking assembly, wherein a channel for a bone pin is defined by an annular element.
Chinese utility model publicationCN 203749538 U discloses a clamping device comprising a clamp body and a locking assembly, wherein a first fastening element can rotate within the openings of the jaws.
Therefore, a need exists for improved external fixation systems, methods, and components for use in fracture fixation.

SUMMARY

The present invention provides a clamping device for an external fixation system as defined by independent claim 1. It includes a clamp body and a locking assembly. The clamp body includes a first jaw and a second jaw. The first jaw and the second jaw define a slot extending between a first surface of the first jaw and a second surface of the second jaw and in communication with a first channel. The first channel is configured to accommodate a first fixation element along a longitudinal axis of the first channel. The first jaw defines a first opening and the second jaw defines a second opening that are sized to receive a portion of the locking assembly. The locking assembly includes a first fastening element configured to pass through the first opening and the second opening, and define a second channel configured to accommodate a bone pin for insertion into a bone of a subject. The locking assembly includes a second fastening element configured to engage with the first fastening element. The locking assembly is configured to restrict movement of the first fixation element relative to the clamp body and restrict movement of the bone pin relative to the clamp body in response to tightening of the locking assembly.
Some or all of the systems, components and subcomponents of the present invention can be single-use or disposable. Also some or all of the systems, components and subcomponents of the present invention can be made of a unitary construction (formed from a single piece of metal or material) or unitary modular construction (plurality of components and/or subcomponents permanently connected by standard means, such as welding or soldering), or of modular construction (plurality of components and/or subcomponents removably connected by standard means, such as threading or snap-fitting).
These and other features of various embodiments can be understood from a review of the following detailed description in conjunction with the accompanying drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the present invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a superior-lateral perspective view of an elbow with a first embodiment of the elbow external fixator and its associated clamps.
FIG. 2 is a superior-medial perspective view of an elbow with the first embodiment of the elbow external fixator and its associated clamps.
FIG. 3 is a superior perspective view of an elbow with the first embodiment of the elbow external fixator and its associated clamps.
FIG. 4 is a detailed anterior-medial exploded view of the first embodiment of the elbow external fixator.
FIG. 5 is a detailed anterior-lateral exploded view of the first embodiment of the elbow external fixator.
FIG. 6 is a perspective view of a first embodiment of a closed clamp that can be utilized in all the embodiments of the external fixator.
FIG. 6A is a cross-sectional view taken along the line 6A-6A ofFIG. 6
FIG. 7 is a perspective view of a double diameter pin that can be utilized in the first embodiment of the closed clamp.
FIG. 8 is an exploded bottom perspective view of the first embodiment of the closed clamp that can be utilized in all the embodiments of the external fixator.
FIG. 9 is an exploded side view of the first embodiment of the closed clamp that can be utilized in all the embodiments of the external fixator.
FIG. 9A is a cross-sectional view taken along theline 9A-9A ofFIG. 9
FIG. 10 is an exploded top perspective view of the first embodiment of the closed clamp that can be utilized in all the embodiments of the external fixator.
FIG. 11 is a perspective view of a first embodiment of an open clamp that can be utilized in all the embodiments of the external fixator.
FIG. 11A is a cross-sectional view taken along theline 11A-11A ofFIG. 11
FIG. 12 is a perspective view of a double diameter pin used in the first embodiment of the open clamp.
FIG. 13 is an exploded top perspective view of the first embodiment of the open clamp that can be utilized in all the embodiments of the external fixator.
FIG. 14 is an exploded side view of the first embodiment of the open clamp that can be utilized in all the embodiments of the external fixator.
FIG. 15 is an exploded bottom perspective view of the first embodiment of the open clamp that can be utilized in all the embodiments of the external fixator.
FIG. 15A is a cross-sectional view of a second embodiment of the open clamp system that can be utilized in all the embodiments of the external fixator.
FIG. 15B is a cross-sectional view of the clamp body ofFIG. 15A.
FIG. 15C is a side view of the shaft ofFIG. 15A.
FIG. 15D is a cross-sectional view taken along the line 15D-15D ofFIG. 15C.
FIG. 16 is a perspective view of a third embodiment of a multiple-part /multiple-material open clamp that can be utilized in all the embodiments of the external fixator.
FIG. 17 is an exploded perspective view of the third embodiment of the multiple-part /multiple-material open clamp that can be utilized in all the embodiments of the external fixator.
FIG. 17A is a cross-sectional view taken along theline 17A-17A ofFIG. 17.
FIG. 18 is a lateral perspective view of an elbow with a second embodiment of the elbow external fixator and its associated clamps.
FIG. 19 is a superior-lateral perspective view of an elbow with the second embodiment of the elbow external fixator and its associated clamps.
FIG. 20 is a posterior-lateral perspective view of an elbow with the second embodiment of the elbow external fixator and its associated clamps.
FIG. 21 is a detailed posterior-lateral exploded view of the second embodiment of the elbow external fixator.
FIG. 21A is a cross-sectional view taken along theline 21A-21A ofFIG. 21.
FIG. 21B is a cross-sectional view taken along theline 21B-21B ofFIG. 21.
FIG. 22 is a detailed anterior-lateral exploded view of the second embodiment of the elbow external fixator.
FIG. 22A is a cross-sectional view taken along theline 22A-22A ofFIG. 22.
FIG. 23 is an anterior perspective view of a leg with a first embodiment of the knee external fixator and its associated clamps.
FIG. 24 is an anterior-medial perspective view of a leg with the first embodiment of the knee external fixator and its associated clamps.
FIG. 25 is an anterior-lateral perspective view of a leg with the first embodiment of the knee external fixator and its associated clamps.
FIG. 26 is a detailed anterior-medial exploded view of the first embodiment of the knee external fixator.
FIG. 27 is a detailed anterior-lateral exploded view of the first embodiment of the knee external fixator.
FIG. 28 is an anterior perspective view of a leg with a second embodiment of the knee external fixator and its associated clamps.
FIG. 29 is an anterior-medial perspective view of a leg with the second embodiment of the knee external fixator and its associated clamps.
FIG. 30 is an anterior-lateral perspective view of a leg with the second embodiment of the knee external fixator and its associated clamps.
FIG. 31 is a detailed anterior-lateral exploded view of the second embodiment of the knee external fixator.
FIG. 32 is a detailed anterior-medial exploded view of the second embodiment of the knee external fixator.
FIG. 33 is an anterior perspective view of a leg with a third embodiment of the knee external fixator and its associated clamps.
FIG. 34 is a superior-medial perspective view of a leg with the third embodiment of the knee external fixator and its associated clamps.
FIG. 35 is a superior-lateral perspective view of a leg with the third embodiment of the knee external fixator and its associated clamps.
FIG. 36 is a detailed superior-lateral exploded view of the third embodiment of the knee external fixator.
FIG. 37 is a detailed superior-medial exploded view of the third embodiment of the knee external fixator.
FIG. 38 is a superior-medial perspective view of a leg with a fourth embodiment of the knee external fixator and its associated clamps.
FIG. 39 is a superior-lateral perspective view of a leg with the fourth embodiment of the knee external fixator and its associated clamps.
FIG. 40 is a detailed superior-medial exploded view of the fourth embodiment of the knee external fixator.
FIG. 41 is a detailed superior-lateral exploded view of the fourth embodiment of the knee external fixator.
FIG. 42 is an anterior-medial perspective view of a leg with a first embodiment of the ankle external fixator and its associated clamps.
FIG. 43 is an anterior-lateral perspective view of a leg with the first embodiment of the ankle external fixator and its associated clamps.
FIG. 44 is a posterior-lateral perspective view of a leg with the first embodiment of the ankle external fixator and its associated clamps.
FIG. 45 is an anterior-medial perspective view of a leg with a second embodiment of the ankle external fixator and its associated clamps.
FIG. 46 is an anterior-lateral perspective view of a leg with the second embodiment of the ankle external fixator and its associated clamps.
FIG. 47 is a posterior-medial perspective view of a leg with the second embodiment of the ankle external fixator and its associated clamps.
FIG. 48 is an anterior-medial perspective view of a leg with a third embodiment of the ankle external fixator and its associated clamps.
FIG. 49 is a medial perspective view of a leg with the third embodiment of the ankle external fixator and its associated clamps.
FIG. 50 is a posterior-lateral perspective view of a leg with the third embodiment of the ankle external fixator and its associated clamps.
FIG. 51 is a detailed posterior-lateral exploded view of the third embodiment of the ankle external fixator.
FIG. 52 is a detailed posterior-medial exploded view of the third embodiment of the ankle external fixator.
FIG. 53 is an anterior-medial perspective view of a leg with a fourth embodiment of the ankle external fixator and its associated clamps.
FIG. 54 is a medial perspective view of a leg with the fourth embodiment of the ankle external fixator and its associated clamps.
FIG. 55 is a posterior-lateral perspective view of a leg with the fourth embodiment of the ankle external fixator and its associated clamps.
FIG. 56 is a detailed posterior-lateral view of the fourth embodiment of the ankle external fixator.
FIG. 57 is a detailed medial view of the fourth embodiment of the ankle external fixator.
FIG. 58 is a detailed posterior-lateral exploded view of the fourth embodiment of the ankle external fixator.
FIG. 59 is a detailed posterior-medial exploded view of the fourth embodiment of the ankle external fixator.
FIG. 60 is a detailed exploded view of the cartridge utilized in the fourth embodiment of the ankle external fixator.
FIG. 61 is a section view of the main body of the cartridge utilized in the fourth embodiment of the ankle external fixator.
FIG. 62 is an anterior-medial perspective view of a leg with a fifth embodiment of the ankle external fixator and its associated clamps.
FIG. 63 is a medial perspective view of a leg with the fifth embodiment of the ankle external fixator and its associated clamps.
FIG. 64 is a posterior-inferior perspective view of a leg with the fifth embodiment of the ankle external fixator and its associated clamps.
FIG. 65 is an anterior-medial perspective view of a leg with a sixth embodiment of the ankle external fixator and its associated clamps.
FIG. 66 is a medial perspective view of a leg with the sixth embodiment of the ankle external fixator and its associated clamps.
FIG. 67 is a posterior-lateral perspective view of a leg with the sixth embodiment of the ankle external fixator and its associated clamps.
FIG. 68 is a detailed posterior-medial exploded view of the sixth embodiment of the ankle external fixator.
FIG. 69 is a detailed posterior-lateral exploded view of the sixth embodiment of the ankle external fixator.
FIG. 70 is a flow diagram of a method of fixating a bone fixator system to a target joint of a subject.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describe and illustrate various exemplary external fixation systems, methods, and components. The description and drawings are exemplary in nature and are provided to enable one skilled in the art to make and use one or more exemplary external fixation systems and/or components, and/or practice one or more exemplary methods. They are not intended to limit the scope of the claims in any manner.
The use of "e.g.," "etc.," "for instance," "in example," and "or" and grammatically related terms indicates non-exclusive alternatives without limitation, unless otherwise noted. The use of "optionally" and grammatically related terms means that the subsequently described element, event, feature, or circumstance may or may not be present/occur, and that the description includes instances where said element, event, feature, or circumstance occurs and instances where it does not. The use of "exemplary" refers to "an example of' and is not intended to convey a meaning of an ideal or preferred embodiment. The use of "attached" and "coupled" grammatically related terms refers to the fixed, releasable, or integrated association of two or more elements and/or devices with or without one or more other elements in between. Thus, the term "attached" or "coupled" and grammatically related terms includes releasably attaching or fixedly attaching two or more elements and/or devices in the present or absence of one or more other elements in between. As used herein, the terms "proximal" and "distal" are used to describe opposing axial ends of the particular elements or features being described in relation to anatomical placement. As used herein, the terms "proximal," "distal," "inferior," "posterior," and any other relative position terms are intended to facilitate clarity regarding the disclosed embodiments, and do not limit the disclosure to any particular frame of reference.
While the systems, methods, and components described herein are exemplified by systems and methods for external fixation of bones, the systems, methods, and components described and illustrated herein can be used to treat any suitable ailment or joint within the body of an animal, including, but not limited to, humans. Skilled artisans will be able to select a suitable ailment and/or joint within the body of an animal to utilize a system and/or method described herein according to a particular embodiment based on various considerations, including the type of ailment and/or the structural arrangement at a treatment site. Example joints considered suitable to utilize a system, method, and/or component described herein include, but are not limited to, the elbow joint, the knee joint, and the ankle joint.
In some embodiments, components disclosed herein may be disposed in a substantially perpendicular orientation (e.g., having longitudinal axes that are less than 20 degrees from 90 degrees apart, less than 10 degrees from 90 degrees apart, less than 5 degrees from 90 degrees apart, less than 1 degree from 90 degrees apart, etc.). In some embodiments, components disclosed herein may be disposed in a substantially coplanar (e.g., being disposed in planes that are less than 20 degrees from coplanar, less than 10 degrees from coplanar, less than 5 degrees from coplanar, less than 1 degree from coplanar, etc.).
Figures1-3 illustrate an exemplaryhuman elbow10 comprising ahumerus12,ulna14, andradius16 and one embodiment of an exemplary elbow-spanningexternal fixation system100.
Figures1-5 illustrate a first embodiment of an exemplary elbow-spanningexternal fixation system100 comprising a firstexternal fixation component102, a secondexternal fixation component104, a fastener or locking means106, a closed-end clamp system300 and an open-end clamp system400. The firstexternal fixation component102 can be adapted to attach to thehumerus12, theulna14 and/or theradius16 by use of the closed-end clamp system300 and/or open-end clamp system400. The secondexternal fixation component104 can be adapted to attach to thehumerus12, theulna14 and/or theradius16 by use of the closed-end clamp system300 and/or open-end clamp system400.
The firstexternal fixation component102, secondexternal fixation component104,fastener106, closed-end clamp system300 and open-end clamp systems400 and500 (shown infigures16-17) can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem100, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form a first external fixation component, a second external fixation component, a fastener, a closed-end clamp system and an open-end clamp system of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
In the illustratedembodiment100 shown infigures1-5, the firstexternal fixation component102 comprises a first component proximal (e.g., first)end portion108 and a first component distal (e.g., second)end portion110. At least a portion of the first componentproximal end portion108 and at least a portion of the first componentdistal end portion110 can be straight or curved. The first componentdistal end portion110 includes apivot structure122 having arough surface124 and a through-bore having a circular cross-sectional shape for receiving a fastener such asfastener106. The secondexternal fixation component104 comprises a second component proximal (e.g., first)end portion112 and a second component distal (e.g., second)end portion114. At least a portion of the second componentproximal end portion112 can be straight or curved. The second componentproximal end portion112 also includes apivot structure126 having arough surface128 and a threaded through-bore132 having a circular cross-sectional shape for receiving a fastener such asfastener106. The firstexternal fixation component102 and secondexternal fixation component104 are coupled and locked via a locking means such as afastener106 having ahead116 and at least a portion of its shaft threaded120. Thefastener106 is configured to extend through the through-bore of thefirst pivot structure122 and the threaded through-bore of thesecond pivot structure126 to form a threaded connection with thesecond pivot structure126 to form a movable hinge, articulator or mechanical joint130. Thehinge130 is then locked in position by further tightening thefastener106 which then interlocks therough surface124 of thefirst pivot structure122 with therough surface128 of thesecond pivot structure126. The interlocking or engagement of therough surfaces124 and128 prevents the first and secondexternal components102 and104 from rotating relatively to each other in a locking state.
Each of the first and secondexternal fixation components102 and104 including theirrespective pivot structures122 and126 can be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy). The first and secondexternal fixation components102 and104 each can have any cross-sectional shape including circular, and non-circular such as oval, square, rectangle, triangle, or any polygonal shapes, and the cross-sectional shape can be different along the length of each component (e.g. semi-circle, circle). Each of the first and secondexternal fixation components102 and104 can have uniform or varying diameter or thickness along its length. The firstexternal fixation component102 can be dimensioned and/or shaped to be the same or different from the secondexternal fixation component104.
Thepivot structures122 and126 can be integrally formed or permanently attached by standard means such as welding or soldering or gluing, or removably coupled by standard means such as threading or snap-fitting, to any locations along the length of their respective first and secondexternal fixation components102 and104 including the portion disposed between the distal end portion and the proximal end portion of eachexternal fixation components102 and104. Thepivot structures122 and126 can have any cross-sectional shape including circular, and non-circular such as oval, square, rectangle, triangle, or any polygonal shape. The length of each of thepivot structures122 and126 as measured along its axis of rotation or mechanical pivot axis X can be the same or different from the diameter or thickness of their respective first and secondexternal fixation components102 and104. The end surfaces124 and128 ofpivot structures122 and126 comprising the rough surface each lies in a plane perpendicularly intersecting the mechanical pivot axis, but can also lie in a plane intersecting the mechanical pivot axis at an angle other than 90 degrees. Therough surfaces124 and128 can include serration or radial interdigitation or other irregularly shaped features which provide friction enhancement or anti-rotation to the fixation components in a locking state. One skilled in the art may choose to have the rough surfaces be disposed on an outer surface of one of the first andsecond pivot structures122 and126 and on an inner surface of the other of the first andsecond pivot structures122 and126 to provide anti-rotation. The rough surfaces can also be provided as separate inserts coupled to thepivot structures122 and126. Thepivot structures122 and126 can be an integral part of their respectiveexternal fixation components102 or104 or can be formed separately and assembled together later by welding, soldering or threading, for example. Thepivot structures122 and126 each can be made of a unitary structure, a unitary modular or multi-component structure, or modular structure. An example of a modular pivot structure may include apivot structure122 or126 having a non-circular cross-sectional shaped through-bore for receiving an insert having a matching, non-circular cross-sectional shape and a circular cross-sectional shaped through-bore with or without threads.
The locking means, such asfastener106, comprises an enlarged structure, such as ahead116, with secure gripping surface features orgeometry118 for ease of handling the fastener during surgery, and ashaft120 having engagement features such as threads which establish a threaded connection with the threaded through-bore132 of thepivot structure126 in the secondexternal fixation component104 during coupling and locking the external fixation components. The engagement features on the shaft can also include fins, protrusions or other fastening features known to one skilled in the art. Thefastener106 can also be a unitary, unitary modular or modular structure. An example of a modular fastener include a fastener as described but without the engagement features on is shaft, and a sleeve having engagement features on its outer surface adapted to cover the shaft of the fastener. The locking means can also include a first fastener such asfastener106 and a second fastener such as a threaded nut. In this exemplary dual fastener system, bothpivot structures122 and126 can have through-bores without threads or any engagement features, and arranged between the head of the first fastener and the nut. As thefirst fastener106 or the second fastener (the threaded nut) is tightened down, theexternal fixation components102 and104 are coupled and locked in position.
Figures6-15 describe various embodiments of a novel bone clamp configured to provide simple locking of various fixation elements such as wires, pins, rods and bars simultaneously. These clamping devices as described below can be used with the external fixation systems of the present invention to couple to bones, or with any existing or commercialized external fixation systems.
Figures6-10 show an embodiment of a closed-end clamp system300 comprising aclamp body302, aknob304 and ashaft306. Theclamp body302 having anopen end302c and a close or hingedend302d connecting anupper jaw302a to alower jaw302b forming a groove oraperture308 for receiving an external fixation element such as the first or secondexternal fixation components102 and104, and a slot or spacing310 in communication with theaperture308. Each of the upper andlower jaws302a and302b have a through-bore000 formed in alignment and configured for receiving and operatively interacting with at least a portion of a locking element or locking assembly such as theshaft306 configured for operably interacting with theknob304 for locking theclamp system300.
Theknob304 comprises a knob body304a having a clampbody facing end304b and anopposing end304c and a through-bore dimensioned for receiving and operatively interacting with a shaft, such asshaft306, and extending longitudinally from the clampbody facing end304b to theopposing end304c. The knob body304a includes a funnel-like or frusto-conicalinternal surface304e or an internal surface having one of more tapered facets to guide, receive and alternatively compress and release a slit end, or a funnel-like or tapered external surface, of a shaft such as theshaft306 for clamping a fixation element such asbone pin600. The funnel-like or frusto-conicalinternal surface304e, or more generally the through-bore bound by walls extending from the clampbody facing end304b to theopposing end304c of the knob body304a, is designed to be larger toward the clampbody facing end304b than toward theopposing end304c of the knob body304a, and includes a first locking feature such asthreads350. The taperedinternal surface304e can also be an insert. The through-bore002 or opening in theopposing end304c of theknob304 has a diameter smaller than the uncompressed diameter of the slit end324 of theshaft306 to provide interference fit among theinner surface304e of theknob304, theslit end324 and the bone pin such asbone pin600. Theopposing end304c of the knob body304a can include one or more slits426a or breakable lines as shown inFigure11A for accommodating a broader range of dimensional tolerances of thebone pin600 or700. Theknob304 can have irregularly shapedgeometry314 for providing a secure grip surface and optionally a hexagonally shapedgeometry316 that interfaces with a wrench.
The variable position shaft orshaft306 includes an elongated body with a through-bore extending longitudinally along its length and dimensioned for receiving a fixation element, such as abone pin600 or700, an end portion including a stopper or an enlarged structure or structures, such ashead318, which operatively interacts with at least a portion of an internal surface of one of said upper and lower jaws, such asjaws302a and302b, for preventing theshaft306 from passing completely through theclamp body302 or through thejaw302a or302b, which thestopper318 first comes in contact with, and a locking or engagement feature such asthreads322 on the external surface of theshaft306, and one or more breakable lines or slits324 on an opposing end portion of the shaft. Theslits324 can also be disposed on thestopper318 to provide similar compression onto thebone pin600 or700 during locking as shown in alternative embodiments of this invention. The taperedinternal surface304e of the knob body304a and the interaction of the engagement features such as thethreads322 and350 guide and releasably compress the slit end324 of theshaft306 to provide clamping of a fixation element, such asbone pin600. In the case where no slits are provided to theend324 of the shaft, or even if slits are provided, theend324 of theshaft306 can be tapered or have a funnel-like shape to match the taperedinternal surface304e of the knob body304a. A portion of theshaft306 or thestopper318 can include an at least partially spherical surface to permit theshaft306, and thus, thebone pin600 or700 disposed in the through-bore of theshaft306 to orient relative to theclamp body302, and can have at least one anti-rotation feature such asprotrusion320 adapted to sit in a key way004 in theclamp body302. Other anti-rotation features can be pins, recesses, splines, and the like. Theshaft306 is configured to extend through theclamp body302 via the through-bores000 in the upper andlower jaws302a and302b and into the through-bore of theknob304 such that thestopper318 is disposed in theclamp body302 and at least a portion of thethreads322 of the shaft and the slit end324 disposed inside the knob body304a. Theshaft threads322 operably engage theinternal threads350 of theknob304 in forming a threaded connection between theshaft306 and theknob304 to form a cannulation or reception for receiving a bone pin such asbone pin600 of uniform diameter orbone pin700 of varying diameter.
In operation, the tightening of theknob304 shortens the distance between theknob304 and thestopper318 and thus, flexes the upper andlower jaws302a and302b towards each other to clamp on an external fixation element such as the first or secondexternal fixation components102 and104 disposed inaperture308. Simultaneously, the slit end324 of theshaft306 is pushed and guided by the taperedinternal surface304e of the knob body304a toward theopposing end304c of theknob304 and compressed circumferentially onto thebone pin600 or700 at theopposing end304c of theknob304 as theslit end324 is pushed through thesmaller opening002 at theopposing end304c of theknob304, and thus, clamping onto thebone pin600 or700 by interference fit.
Theclamp body302 can include an annular protrusion such as a convexannular protrusion312 disposed adjacent to the through-bore of theupper jaw302a for operably engaging with the clampbody facing end304b of theknob304 for secure engagement. Theannular protrusion312 can have engagement features on its external convex surface to lock angularly with other engagement features on an underside of the clampbody facing end304b of theknob304.
Figures11-15 illustrate analternative embodiment400 of the closed-end clamp system300. The open-end clamp device400 is similar in design to the closed-end clamp device300 except that the groove oraperture408 is disposed adjacent to theopen end402c of theclamp body402. The outer edges of the sides of the groove oraperture408 along its length are chamfered to allow theclamp system400 to easily snap onto a fixation element such asfixation components102 and104. Theknob404 has an undersurface428 having a rough surface such as a radial interdigitation pattern operably engaging aconvex protrusion412 having a rough surface such as circular steps disposed adjacent to the through-bore in theupper jaw402a.
Figures15A -15D illustrate analternative embodiment2600 of the open-end clamp system400. The open-end clamp system2600 comprises aclamp body2602, aknob2604 and ashaft2606. Theclamp body2602 having anopen end2602c and a close or hingedend2602d connecting anupper jaw2602a to alower jaw2602b forming a groove oraperture2608 for receiving an external fixation element such as the first or secondexternal fixation components102 and104, and a slot or spacing2610 in communication with theaperture2608. The upper andlower jaws2602a and2602b have through-bores2000a and2000b formed in at least partial alignment and dimensioned for receiving at least a portion of a locking element or assembly, such as the illustrated assembly comprising theknob2604 and theshaft2606. One of the through-bores2000a and2000b of the upper andlower jaws2602a and2602b, such as through-bore2000b, defines a first diameterD1 and a second diameterD2, whereinD1 is smaller and located closer to theslot2610. Theinner surface2602e containingD1 andD2 is shown as partially spherical, but it can be conical, partially conical or frusto-conical, or faceted. Theinner surface2602e is configured and dimensioned to operatively interact with an external surface of a slit portion of theshaft2606 to clamp onto a fixation element, such asbone pin600 or700, received in a through-bore formed along a length of theshaft2606.
Theknob2604 comprises a longitudinally formed through-bore having an internal thread and dimensioned for receiving and operatively interacting with theshaft2606. Other engagement features, such as tabs and fins, can be used in place of or in addition to the thread on the internal surface of theknob2604. The opposingend2604c of theknob body2604 can include one or more slits, such as slits426a as shown inFigure11A for accommodating a broader range of dimensional tolerances of thebone pin600 or700. Theknob2604 can have an external surface and/or shape for providing a secure grip surface and optionally a hexagonally shaped geometry that interfaces with a wrench.
The variable position shaft orshaft2606 includes an elongated body with a through-bore extending longitudinally along its length and dimensioned for receiving a fixation element, such as abone pin600 or700, a locking or engagement feature such asthreads2622 on the external surface of theshaft2606, and a stopper or an enlarged structure, such ashead2618, formed with one ormore slits2624 extending longitudinally along at least a portion of the length of theshaft2606, and operatively interacting with at least a portion of an inner surface of one of said upper and lower jaws, such asinner surface2602e, for compressing theslit stopper2618 to clamp onto thebone pin600 or700. Theinner surface2602e also, but not necessary, prevents theshaft2606 from passing completely through theclamp body2602, or through at least one of thejaws2602a or2602b which thestopper2618 first comes in contact with, such as thejaw2602b. Other features and designs on the inner surface of theclamp body2602, or of any of its upper and lower jaws that operatively interact with at least a portion of theshaft2606 to prevent theshaft2606 from passing completely through are still within the spirit and scope of the present invention. Thestopper2618 has a partially spherical external shape and at least one anti-rotation feature, such asanti-rotation pin2620 configured to mate with a feature, such as a key way, on an inner surface of theclamp body2602. Other anti-rotation features can be splines, recesses, protrusions or the like. Other shapes including conical and faceted external shapes of the stopper are considered within the spirit and scope of the present invention. The through-bore of theshaft2606 and the width of theslit2624 are dimensioned to receive a fixation element, such asbone pin600 or700, with very little play between theshaft2606 and thebone pin600 in an uncompressed state and a tight fit between theshaft2606 and thebone pin600 or700 in a compressed state. Theshaft2606 can comprise a tapered end. Theengagement feature2622 on the external surface of theshaft2606 can have other forms such as fins and tabs for interacting with the corresponding engagement feature on the inner surface of theknob2604 to form a mechanical connection for clamping the fixation components and elements. Theshaft2606 is configured to extend through theclamp body2602 via the through-bores in the upper andlower jaws2602a and2602b and into the through-bore of theknob2604 such that thestopper2618 is disposed in theclamp body2602 and at least a portion of thethreads2622 of the shaft is disposed and operatively interacts with the threads on the inner surface of the knob2604a.
Figures16 -17 and17A describe analternate embodiment500 of the open-end clamp system400. The open-end clamp system500 is of a modular type. The open-end clamp system500 is similar to the open-end clamp system400 except that the convexannular protrusion512 being a two-piece insert made of a separateupper part504 and a separatelower part506, and each of theparts504 and506 being formed with two key ways matching the key ways on the inner surfaces of the through-bores in the upper andlower jaws502a and502b of theclamp body502 for receiving the anti-rotation features320, or420. The open-end clamp system500 further includes a separate clip or insert508 disposed between the upper andlower jaws502a and502b of theclamp body502 for modifying the space therein. Theinsert508 including anupper jaw jacket508a connected to a lower jaw jacket508b to form aninsert groove518 for laterally receiving a fixation element such asfixation components102 or104. A through-bore is formed in each of said upper andlower jaw jackets508a and508b of theinsert508 and aligned with aligned through-bores formed in the upper andlower jaws502a and502b of theclamp body502 for receiving the convexannular protrusion insert512. Theinsert508 includes a slot or spacing between saidjaw jackets508a and508b and in communication with saidinsert groove518 to allow the upper andlower jaws502a and502b of theclamp body502 and thejaw jackets508a and508b of theinsert508 to flex during locking and unlocking of theclamp system500. Theinsert508 is configured to have an outer cross-sectional shape (Figure17A) being substantially the same as an inner cross-sectional shape of theclamp body502 to allow theinsert508 to easily slide into the space between the upper andlower jaws502a and502b of theclamp body502 and mate or attach to the inner surface of theclamp body502. Theinsert groove518 can include splines to help secure gripping onto the fixation element.
Although the foregoing exemplary embodiments describe clamping systems having upper and lower jaws joined together by a hinged or closed end, the clamping systems of various embodiments of the present invention can comprise two or pairs of two separate upper and lower jaws spaced apart via a flexible structure, such as a spring coil surrounding a fastener, such asshaft306, extending through the through-bores in the upper and lower jaws of the clamp to form one or more grooves for receiving external fixation elements such as rods, bars, pins, and a slot between the upper and lower jaws to allow the jaws to flex during locking and unlocking.
Figures18-20 show an exemplary embodiment of an elbow-spanning hingedexternal fixation system200 using the external fixator system including the novel clamp devices of the present invention. Thesystem200 is coupled to ahuman elbow10 comprising ahumerus12,ulna14, andradius16.Figures21-22 show exploded views of the hinge or articulator of thesystem200.
Now referring tofigures18-22, the elbow-spanning hingedexternal fixation system 200 comprising a firstexternal fixation component202, a secondexternal fixation component204, afastener206, a closed-end clamp system300 and an open-end clamp system400. The firstexternal fixation component202 can be adapted to attach to thehumerus12, theulna14 and/or theradius16 by use of the closed-end clamp system300 and/or open-end clamp system400 and fixation elements such as bone pins. The secondexternal fixation component204 can be adapted to attach to thehumerus12, theulna14 and/or theradius16 by use of the closed-end clamp system300 and/or open-end clamp system400.
The firstexternal fixation component202, secondexternal fixation component204,fastener206, closed-end clamp system300 and open-end clamp system400 can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem200, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form a first external fixation component, a second external fixation component, a fastener, a closed-end clamp system and an open-end clamp system of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
In the illustratedembodiment200 infigures18-22, the firstexternal fixation component202 comprises a first component proximal (e.g., first)end208 having a straight portion with circular cross-sectional shape (Figure21A) and a first component distal (e.g., second) end210 comprising a curved portion with a semi-circular cross-sectional shape (Figure21B) formed with afirst pivot structure222 having a circular cross-sectional shape (Figure22A), and a through-bore with aninternal thread232 and arough end surface224. The first componentproximal end208 can be straight or curved. The secondexternal fixation component204 comprises a straight portion of cylindrical structure and a curved portion with semi-circular cross-sectional shape (Figure21B), a second component distal (e.g., first)end214 and a second component proximal (e.g., second) end212 comprising the curved portion formed with asecond pivot structure226 having a circular cross-sectional shape (Figure22A), a through-bore with no internal threads and arough end surface228. The second componentdistal end214 can be straight or curved. Each of the first and secondexternal fixation components202 and204 including theirrespective pivot structures222 and226 can be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy). Afastener206 having threads on itsshaft220 is configured to extend through the through-bore in thecylindrical pivot structure226 of the secondexternal fixation component204 and the through-bore in thecylindrical pivot structure222 of the firstexternal fixation component202, and forms a threaded connection with thecylindrical pivot structure222. The firstexternal fixation component202 and secondexternal fixation component204 are attached to each other via thefastener206 to form a movable hinge or joint230. This movable hinge or joint230 is then fixed in position by further tightening thefastener206 which then interlocks therough end surface224 of thefirst pivot structure222 with therough end surface228 of thesecond pivot structure226. Thus, the firstexternal fixation component202 and thesecond fixation component204 are now locked in position to reduce the bone fracture. Thefastener206 can have adistal end216 with irregularly shapedexternal geometry218 to provide a secure gripping surface, and ashaft220 with engagement features that can interface with the engagement features such as fins orthreads232 in the secondexternal fixation component204.
The elbow-spanning hingedexternal fixation system200 uses a combination of foregoing described embodiments ofnovel clamp systems300, 400, and500 for coupling theexternal fixation system200 to the bone for fixing bone injury. This novel hingedsystem200 significantly reduces surgical time by providing surgeons with flexibility in using the system on either side of the joint/body without having to align the mechanical pivot axis with the natural pivot axis of the joint, and ease of locking multiple fixation elements at once with a single tightening of a knob.
Referring now tofigures23-25, a first embodiment of an exemplary knee-spanningexternal fixation system800 is illustrated mounted on alower extremity18 comprising afemur20,tibia22,fibula24 and afoot26.
Figures23-27 illustrate a first embodiment of an exemplary knee-spanningexternal fixation system800 comprising a firstexternal fixation component802, a secondexternal fixation component804, afirst fastener806, asecond fastener808, a closed-end clamp system300 and an open-end clamp system400. The firstexternal fixation component802 can be adapted to couple to thefemur20, thetibia22, thefibula24 and/or thefoot26 by use of the closed-end clamp system300 and/or open-end clamp system400. The secondexternal fixation component804 can be adapted to attach to thefemur20, thetibia22, thefibula24 and/or thefoot26 by use of the closed-end clamp system300 and/or open-end clamp system400.
The firstexternal fixation component802, secondexternal fixation component804,first fastener806,second fastener808, closed-end clamp system300 and open-end clamp system400 can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem800, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form a first external fixation component, a second external fixation component, a fastener, a closed-end clamp system and an open-end clamp system of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
In the illustratedembodiment800 infigures23-27, the firstexternal fixation component802 comprises a straight portion of cylindrical structure and a curved portion also of cylindrical structure, a first component proximal (e.g., first)end810 and a first component distal (e.g., second) end812 comprising the curved portion formed with a pivot structure ofcylindrical body814 having a through-bore bound by smooth walls extending along its pivot axis and further having arough end surface834. The first componentproximal end810 can be straight or curved. The secondexternal fixation component804 comprises a straight portion of cylindrical structure and a curved portion also of cylindrical structure, a second component distal (e.g., first)end818 and a second component proximal (e.g., second) end816 comprising the curved portion formed with a pivot structure ofcylindrical body820 having a through-bore bound by smooth walls extending along its pivot axis and arough end surface836. The second componentdistal end818 can be straight or curved. Thepivot structures814 and820 each has a length along the pivot axis such that when the twopivot structures814 and820 are joined end to end at their rough surfaces by a fastener, such as806 or808, the firstexternal fixation component802 and the secondexternal fixation component804 are disposed on different sides of the bone or knee (e.g., right side, left side, anterior, posterior). Each of the first and secondexternal fixation components802 and804 including theirrespective pivot structures814 and820 can be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy). Afastener806 havingthreads826 on its shaft is configured to extend through the through-bore in thecylindrical pivot structure814 of the firstexternal fixation component802 and the through-bore in thecylindrical pivot structure820 of the secondexternal fixation component804 and into a second fastener such as a threadednut808, and forms a threaded connection with thenut808. The firstexternal fixation component802 and secondexternal fixation component804 are thus attached to each other via the coupling and interactions of thepivot structures814 and820 and thefasteners806 and808 to form a movable hinge or joint838. This movable hinge or joint838 is then locked in position by further tightening thefasteners806 and808 which interlocks therough end surface834 of the firstexternal fixation component802 with therough end surface836 of the secondexternal fixation component804. Thefastener806 can have a distal end orhead822 with irregularly shapedexternal geometry824 to provide a secure gripping surface, and a shaft with engagement features such asthreads826 that can interface with the engagement features such as fins or threads inside thesecond fastener808. Similarly, thesecond fastener808 can also have an outer surface geometry for secure gripping surface.
Figures28-32 illustrate analternative embodiment900 of the exemplary knee-spanningexternal fixation system800 comprising a firstexternal fixation component902, a secondexternal fixation component904, afirst fastener906, asecond fastener908 and an open-end clamp system400. The firstexternal fixation component902 can be adapted to attach to thefemur20, thetibia22, thefibula24 and/or thefoot26 by use of the closed-end clamp system300 and/or open-end clamp system400. The secondexternal fixation component904 can be adapted to attach to thefemur20, thetibia22, thefibula24 and/or thefoot26 by use of a closed-end clamp system300 and/or open-end clamp system400.
The exemplary knee-spanningexternal fixation system900 is similar to the foregoing describedsystem800 except that the lockable and movable hinge of the knee-spanningexternal fixation system900 is dimensioned to accommodate a wider joint or bone size. This is made possible by designing thepivot structures914 and920 to have a longer length along their mechanical pivot axis for accommodating a broader range of pin sites and/or body or joint sizes.
Figures33-37 show a third embodiment of an exemplary knee-spanningexternal fixation system1000 for mounting on alower extremity18 comprising afemur20,tibia22,fibula24 and afoot26.
The third embodiment of an exemplary knee-spanningexternal fixation system1000 comprises a firstexternal fixation component1002, a secondexternal fixation component1004, afirst fastener1006, asecond fastener1008 and an open-end clamp system400 or a close-end clamp system300. The firstexternal fixation component1002 can be adapted to couple to thefemur20, thetibia22, thefibula24 and/or thefoot26 by use of the closed-end clamp system300 and/or open-end clamp system400. The secondexternal fixation component1004 can be adapted to couple to thefemur20, thetibia22, thefibula24 and/or thefoot26 by use of a closed-end clamp system300 and/or open-end clamp system400.
The firstexternal fixation component1002, secondexternal fixation component1004,first fastener1006,second fastener1008 and open-end clamp system400 and optionally close-end clamp system300 can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem1000, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form a first external fixation component, a second external fixation component, a fastener, a closed-end clamp system and an open-end clamp system of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
In the illustratedembodiment1000 infigures33-37, the firstexternal fixation component1002 having an "L" shape and a circular cross-sectional shape, comprises a first component proximal (e.g., first)end portion1010 and a first component distal (e.g., second)end portion1012. The first componentdistal end portion1012 comprises the shorter leg of the "L" shape and is coupled to or formed at its open end a pivot structure ofcylindrical body1014 having a through-bore bound by smooth walls extending along its pivot axis and arough end surface1034. The first componentdistal end portion1012 comprises a straight middle segment connecting two curved end segments. However, these segments can all be straight or curved. The first componentproximal end1010 can be straight or curved. The secondexternal fixation component1004 having an inverted "L" shape, comprises a second component proximal (e.g., second)end portion1016 and a second component distal (e.g., second)end portion1018. The second componentproximal end portion1016 comprises the shorter leg of the inverted "L" shape and is coupled to, or formed at, its open end a pivot structure ofcylindrical body1020 having a through-bore bound by smooth walls extending along its pivot axis and arough end surface1036. The second componentproximal end portion1016 comprises a straight middle segment connecting two curved end segments. However, these segments can all be straight or curved. The second componentdistal end portion1018 can be straight or curved. Thepivot structures1014 and1020 each has a length along the pivot axis such that when the twopivot structures1014 and1020 are joined end to end at theirrough surfaces1034 and1036 by a fastener, the firstexternal fixation component1002 and the secondexternal fixation component1004 are disposed on different sides of the bone or knee (e.g., right side, left side, anterior, posterior). Each of the first and secondexternal fixation components1002 and1004 including theirrespective pivot structures1014 and1020 can be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy).
Afastener1006 havingthreads1026 on its shaft is configured to extend through the through-bore in thecylindrical pivot structure1014 of the firstexternal fixation component1002 and the through-bore in thecylindrical pivot structure1020 of the secondexternal fixation component1004 and into a second fastener such as a threadednut1008, and forms a threaded connection with thenut1008. The firstexternal fixation component1002 and secondexternal fixation component1004 are thus attached to each other viafasteners1006 and1008 to form a movable hinge or joint1038. This movable hinge or joint1038 is then locked in position by further tightening thefasteners1006 and1008 which interlocks therough end surface1034 of thepivot structure1014 with therough end surface1036 of thepivot structure1020. Thefastener1006 can have a distal end orhead1022 with irregularly shapedexternal geometry1024 to provide a secure gripping surface, and a shaft with engagement features such asthreads1026 that can interface with the engagement features such as fins or threads inside thesecond fastener1008. Similarly, thesecond fastener1008 can also have an outer surface geometry for secure gripping surface.
In this exemplary embodiment, the first componentdistal end portion1012 and the second componentproximal end portion1016 form a right angle with their respective first componentproximal end portion1010 and second componentdistal end portion1018. One skilled in the art can select other angles such as 60 or 120 degrees to accommodate the type of fracture or body shape, for example. Other shapes and dimensions of the first and secondexternal fixation components1002 and1004 also are within the spirit and scope of various embodiments of the present invention. Similarly, the angles(θ1, θ2) between thepivot structures1014 and1020 and their respective first componentdistal end portion1012 and second componentproximal end portion1016 are 90 degrees as schematically illustrated infigures33-37, but angles other than 90 degrees are contemplated and within the spirit and scope of various embodiments of the present invention.
The firstexternal fixation component1002 and the secondexternal fixation component1004 including theirrespective pivot structures1014 and1020 can each be formed as a unitary modular structure or a modular structure. In the case of a unitary modular structure, for example, the firstexternal fixation component1002 can be formed from a single rod or bar and bent into the "L" shape, and welded to thepivot structure1014. In the case of a modular structure, the firstexternal fixation component1002 and thepivot structure1014 can be formed by removably connecting plurality of straight and/or curved rod segments and thepivot structure1014 by snap-fitting, or threading, for example. The first and secondexternal fixation components1002 and1004 and thepivot structures1014 and1020 can have any cross-sectional shapes (e.g. hexagonal, oval, square) and dimensions other than the circular cross-sectional shape as schematically illustrated infigures33-37.
Referring now tofigures38-39, analternative embodiment1100 of the exemplary knee-spanningexternal fixation system1000 is shown mounted by pins on thelower extremity18 comprising afemur20,tibia22,fibula24 and afoot26.
The knee-spanningexternal fixation system1100 illustrated infigures38-41 is similar to exemplary knee-spanningexternal fixation system1000 infigures33-37 except that the first component distal (e.g., first)end1112 and the second component proximal (e.g., second)end1116 are each connected to theirrespective pivot structures1114 and1120 at an angle greater than 90 degrees (θ3, θ4).
Figures42-69 show various exemplary ankle-spanning external fixation systems, some are of unitary, prefabricated modular construction (e.g. from multiple pieces welded together), or unitary construction (e.g. from a single piece of material by molding), while others are of modular construction (e.g. multiple pieces removably threaded together to allow surgeons to use the assembled system as is or to reconfigure the assembled system to match the patient anatomy). The illustrated ankle-spanning external fixation systems comprise a proximal or upper frame coupled to a distal or lower frame such as the curved foot frame including a posterior frame segment extending angularly from and above an inferior frame segment designed for placement and use substantially adjacent to the ankle area of the body to protect both the posterior and the inferior of a foot or ankle while healing is taken place. The system can be used adjacent to other joints such as the elbow or the knee, and is capable of being any shape and size that allows for support of the joint and area round the joint such as the foot, ankle, and/or lower extremity.
Referring now tofigures42-44, a first embodiment of an exemplary ankle-spanningexternal fixation system1200 is shown mounted via pins on an exemplarylower extremity28 comprising atibia32,fibula34 and afoot36. Thefixation system1200 includes one or more open-end clamps400 and1300 and optionally closed-end clamps for clamping fixation elements such as bars, rods, pins, or wires of various diameters.
Theexternal fixation system1200 and open-end clamp systems400 and1300 can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem1200, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form thesystem 1200 of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
The illustratedembodiment1200 infigures42-44 comprises two ankle-spanningexternal fixation systems1200 which are substantially the same and mounted on each side of the foot to protect the ankle and area around the ankle. Eachexternal fixation system1200 comprises a single piece, unitary prefabricated modular frame comprising a proximal (e.g., first)frame1200a, aconnector1214 and1216 and a distal (e.g., second)frame1212 attached together by standard means, such as welding, soldering, brazing, crimping, or adhesives. The proximal frame defines a single bar or rod such asbar1200a including a proximal (e.g., first)end portion1202 and a distal (e.g., second)end portion1204 and acurved portion1206 connecting the proximal anddistal end portions1202 and1204. Thedistal end1204 can be of a reduceddiameter1208 and comprises an extension oroutrigger1210 which can be divided into two or more branches, such asbifurcation1220, for attaching a clamp such as the open-end clamp system300 or closed-end clamp system400. A distal frame, such as thefoot frame1212, configured to capture the posterior and the inferior aspects of a joint, such as the ankle, comprising two parallelcurved rods1218, is coupled to the proximal frame, such as thebar1200a, via a Y-shaped connector having twoarms1216 and atrunk1214. Other shapes of the connector also are within the spirit and scope of various embodiments of the present invention. Eachcurved rod1218 comprises a straight inferior (e.g., first) frame section orportion1218a and a straight posterior (e.g., second) frame section orportion1218b and a curved frame section orportion1218c connecting the straightinferior frame section1218a to the straightposterior frame section1218b, wherein saidinferior frame portion1218a and saidposterior frame portion1218b are operatively disposed in at least partially surrounding and spatial relation to the ankle or the heel of thefoot36, wherein saidposterior frame portion1218b extends angularly from and above saidinferior frame portion1218a. Eacharm1216 of the Y-shaped connector connects to one of therods1218 of thefoot frame1212 at the concave surface side of the curved frame section, and thetrunk1214 of the Y-shaped connector connects to thecurved portion1206 of the proximal frame such as thebar frame 1200a at the convex surface side of thecurved portion1206.
Thefoot frame1212 is generally configured to capture the posterior and the inferior aspects of a foot or ankle and thus may take various shapes as illustrated in other exemplary embodiments. In the single piece, unitary modular construction, the proximal anddistal frames1200a and1212 and connector(s)1214 and1216 and their subcomponents such asoutrigger1220 can be welded, soldered, crimped, brazed or glued/epoxied together during manufacturing. Alternatively, in a unitary construction, theproximal frame1200a, theconnector1214 and1216 and thedistal frame1212 and optionally any subcomponents such as anoutrigger1220 may be integral-machined or formed from a single piece of metal or other material by standard means such as molding or machining. In a multi-piece, or modular construction, the proximal anddistal frames1200a and1212 andconnector1214 and1216 and theirsubcomponents1220 can be removably connected by standard means such as threads, plug-socket joint, snap-fit, interference fit or a combination thereof during manufacturing or immediately prior to use to provide surgeons the flexibility of design choices to fit the patient anatomy. The proximal anddistal end portions1202 and1204 of thebar frame1200a and the Y-shaped connector may be formed of various curved and/or straight pieces or subcomponents connected together and may have any profiles. The components of thesystem1200 are shown as having circular cross-sectional shape. Other cross-sectional shapes such as hexagonal shape, square, rectangle, for example, are within the spirit and scope of the various embodiments of the present invention.
Referring now tofigures45-47, analternative embodiment 1400 of the exemplary ankle-spanningexternal fixation system 1200 is shown mounted by pins on thelower extremity28 comprising a femur30,tibia32,fibula34 and afoot36, wherein the foot frame is of a different design.
The exemplary ankle-spanningexternal fixation system1400 comprises a single piece, unitary prefabricated modular frame comprising a proximal (e.g., first) frame1400a, aconnector1414 and a distal (e.g., second)frame1412 attached together by standard means such as welding, soldering, brazing, crimping, or adhesives. Alternatively, the proximal frame, the connector and the distal frame may be integral-machined or formed from a single piece of metal or other material by standard means such as molding or machining. The exemplary ankle-spanningexternal fixation system1400 comprises a proximal frame such as bar frame1400a coupled to a distal frame such as afoot frame1412 via aframe connector1414 wherein the foot frame comprises a continuous elongated ring frame having a U-shaped inferior (e.g., first)frame section1418 lying in a first plane and a U-shaped posterior (e.g., second)frame section1416 lying in a second plane and acurved section1420 connecting each of the legs of the U-shapeinferior frame section1418 to each of those of the U-shapedposterior frame section1416 to form a closed loop. Other shapes of the inferior and posterior frame portions are also within the spirit and scope of various embodiments of the present invention. The first and second planes containing theinferior frame section1418 and theposterior frame section1416 are perpendicular to each other as schematically illustrated. However, the angle between the first and second planes can be other than 90 degrees, such as 60 degrees or 120 degrees. Saidinferior frame portion1418 and saidposterior frame portion1416 are operatively disposed in at least partially surrounding and spatial relation to the ankle or the heel of thefoot36, wherein saidposterior frame portion1416 extends angularly from and above saidinferior frame portion1418. In the single piece, unitary modular construction, the proximal anddistal frames1400a and1412 and connector(s)1414 and their subcomponents such asoutrigger1410 can be welded, soldered, crimped, brazed or glued/epoxied together during manufacturing. Alternatively, in a unitary construction, the proximal frame1400a, theconnector1414 and thedistal frame1412 and optionally any subcomponents such as anoutrigger1410 may be integral-machined or formed from a single piece of metal or other material by standard means such as molding or machining. In a multi-piece, or modular construction, the proximal anddistal frames1400a and1412 andconnector1414 and theirsubcomponents1410 can be removably connected by standard means, such as threads, plug-socket joint, snap-fit, interference fit or a combination thereof during manufacturing or immediately prior to use to provide surgeons the flexibility of design choices to fit the patient anatomy. All the components of the frames and the frame connector can have circular cross-sectional shape as shown or can have other cross-sectional shape including square, oval, hexagon, or others. Each of the proximal and distal frames can be made from a single rod/bar or a plurality of straight and/or curved bar/rod segments or subcomponents connected together end-to-end using welding, soldering, gluing, brazing, crimping, threading, snap-fitting or the like.
Referring now tofigures48-50, a third embodiment of an exemplary ankle-spanningexternal fixation system1500 is illustrated mounted on alower extremity28 comprising atibia32,fibula34 and afoot36.
Figures48-52 illustrate a third embodiment of an exemplary ankle-spanningexternal fixation system1500 comprises a proximal frame including a firstexternal fixation component1502a, a second external fixation component1502b, and afastener1506, and connecting to a distal (e.g., first) frame such asfoot frame1504, and open-end clamp systems400 and1300. The ankle-spanningexternal fixation system1500 can be adapted to couple to thetibia32, thefibula34 and/or thefoot36 by use of a closed-end clamp system300 and/or the open-end clamp systems400 and1300.
The first and secondexternal fixation components1502a and1502b, and thefoot frame1504,fastener1506 and open-end clamp systems400 and1300 can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem1500, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form the first external fixation component, the second external fixation component, the foot frame, the fastener, and the open-end clamp systems of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
In the illustratedembodiment1500 infigures48-52, a proximal (e.g., second) bar frame comprises a firstexternal fixation component1502a comprising a straight first component proximal (e.g., first)end portion1508 and a curved first component distal (e.g., second)end portion1510 including afirst pivot structure1512a comprising a rough surface1514a and a threaded shaft centered and formed perpendicularly on the rough surface1514a, and said firstexternal fixation component1502a pivotedly coupled and locked to a second external fixation component1502b comprising a straight second component proximal (e.g., first)end portion1534, a straight second component distal (e.g., second)end portion1518 of a reduced diameter, and a curved orarc portion1532 connecting the second componentproximal end portion1534 and a second componentdistal end portion1518, saidarc portion1532 having apivot structure1512b with a rough surface1514b and a centered through-bore for receiving the threaded shaft of thepivot structure1512a to form a movable joint or hinge. A fastener, such as threadednut1506, is coupled to the threaded shaft of thefirst pivot structure1512a to form a threaded connection to lock the movable joint, thus, also locking the first and secondexternal fixation component1502a and1502b in place. The interaction between the rough surfaces1514a and1514b in a locking state provides anti-rotation to the first andsecond fixation components1502a and1502b. The second componentproximal end portion1534 is attached by, for example, welding, soldering or gluing to a distal frame, such as thefoot frame1504, to form a unitary, prefabricated modular structure. Alternatively, thefoot frame1504 can be integrally machined or formed with the second external fixation component1502b from a single piece of metal or other material to form a unitary structure. Thefoot frame1504 comprises astraight posterior segment1516a, a straightinferior segment1516b, and a curved or arc segment1516c connecting thestraight posterior segment1516a and the straightinferior segment1516b to form a curved frame or rod or bar for protecting and supporting both the posterior and the inferior aspects of a foot or joint such as the ankle while healing is taken place. Saidinferior frame portion1516b and saidposterior frame portion1516a are operatively disposed in at least partially surrounding and spatial relation to the ankle or the heel of thefoot 36, wherein saidposterior frame portion1516a extends angularly from and above saidinferior frame portion1516b. The second componentdistal end portion1518 has a smaller diameter and is attached (e.g. welded, soldered or glued) to anoutrigger1522 used as a clamp attachment, for example. Theoutrigger1522 can also be integrally machined or formed with the second external fixation component1502b.
The first and second componentproximal end portions1508 and1534, the first and second componentdistal end portions1510 and1518, and more generally the first and secondexternal fixation components1502a and1502b and the posterior andinferior segments1516a and1516b can be straight or curved. The first and secondexternal fixation components1502a and1502b and thefoot frame1504 of thesystem1500 can have any cross-sectional shapes such as circle, square, rectangle, hexagon, etc., and can have uniform diameter or varied diameter along their lengths. The first and secondexternal fixation components1502a and1502b including thefoot frame1504 of thesystem1500 can each be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy).
Thepivot structures1512a and1512b can have any cross-sectional shapes, not just limited to a circular shape as illustrated in this example. Thepivot structures1512a and1512b can also have any lengths or thickness as measured along its pivot axis. Thepivot structures1512a and1512b of the movable hinge or joint can each also be an integral part of (e.g. integrally formed with) or a separate part to (e.g. removably coupled to) their respective firstexternal fixation component1502a and second external fixation component1502b. The rough surfaces1514a and1514b can include serration or radial interdigitation or combinations thereof. In a system where bothpivot structures1512a and1512b each comprises a through-bore, a second fastener having a head and a threaded shaft can be used to couple thepivot structures1512a and1512b and operably interacts with the threadednut1506 to lock thepivot structures1512a and1512b. The fastener(s) can have a secure gripping surface for ease of handling during surgery. As illustrated, the firstexternal fixation component1502a and the second external fixation component1502b including thefoot frame1504 each is made as a unitary modular structure. In the modular structure, the firstexternal fixation component1502a and the second external fixation component1502b and thefoot frame1504 can each be made from a plurality of straight and/or curved segments connected via threads, snap-fit or interference fit.
Referring now tofigures53-57, a fourth embodiment of an exemplary ankle-spanningexternal fixation system1600 is shown mounted on an exemplarylower leg28 comprising atibia32,fibula34 and afoot36.
Figures53-61 illustrate a fourth embodiment of an exemplary ankle-spanningexternal fixation system1600 comprising a proximal (e.g., first) frame having a firstexternal fixation component1602 and a secondexternal fixation component1604, aproximal frame connector1606, and a distal (e.g., second) frame or afoot frame1608, adistal frame connector1650, acartridge system1610 and an open-end clamp system400. The ankle-spanningexternal fixation system1600 can be adapted to attach to thetibia32, thefibula34 and/or thefoot36 by use of a closed-end clamp system300 and/or the open-end clamp systems400 and1300 and other fixation elements such as bone pins600 or700.
The firstexternal fixation component1602, the secondexternal fixation component1604, the proximal (e.g., first)frame connector1606, thefoot frame1608, the distal (e.g., second)frame connector1650, thecartridge system1610 and the open-end clamp system400 can be formed of any suitable material known to one skilled in the art that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to thesystem1600, including the structural arrangement at a fixation site and/or the material forming the components of an external fixation system. Example suitable materials include, but are not limited to, biocompatible materials, materials that can be made biocompatible, ceramics, polymers, polyethylene, ultra-high-molecular-weight polyethylene (UHMWPE), shape memory polymer, carbon fiber, metal, metal alloy, shape memory metals, tantalum, titanium (Ti), and cobalt alloys (e.g., cobalt-chromium (CoCr), cobalt-chromium-molybdenum (CoCrMo)). The material is also preferably, but not necessarily, radiolucent. It is considered advantageous to form the first external fixation component, the second external fixation component, the third external fixation component, the fourth external fixation component, the cartridge system and the open-end clamp system of aluminum, stainless steel and/or carbon fiber, at least because these materials have properties that are well suited to external fixation of fractures.
In the illustratedembodiment1600 infigures53-61, the proximal frame comprises the firstexternal fixation component1602 and the secondexternal fixation component1604. Theexternal fixation component1602 comprises a first component proximal (e.g., first)end portion1612 and a first component distal (e.g., second)end portion1614 integrally formed with or coupled to apivot structure1616 having arough surface1618 and a through-bore bound by an inner surface having engagement features such as threads andkey ways1620 configured for receiving and connecting to at least a portion of thecartridge system1610 for coupling to a bone and locking thesystem1600. The secondexternal fixation component1604 comprises a second component distal (e.g., first)end portion1624 and a second component proximal (e.g., second)end portion1622 integrally formed with or coupled to apivot structure1626 having arough surface1628 and a through-bore bound by an inner surface having engagement features such as threads andkey ways1630 configured for receiving and connecting to at least a portion of thecartridge system1610 for coupling to a bone and locking theexternal fixation components1602 and1604 in position.
The first and secondexternal fixation components1602 and1604 can be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy). The first and second componentproximal end portions1612 and1622 and the first and second componentdistal end portions1614 and1624 can be straight or curved. The first and secondexternal fixation components1602 and1604 can have any cross-sectional shapes such as circle, oval, triangle, rectangle, square, polygonal shape. The first and secondexternal fixation components1602 and1604 can have any uniform or varied diameter or thickness along their lengths. Thepivot structures1616 and1626 can have any external cross-sectional shapes, not limited to just circular shape as illustrated in this example. Thepivot structures1616 and1626 can also have any lengths or thickness as measured along its pivot axis. Thepivot structures1616 and1626 can also be integrally formed with or removably coupled to their respective firstexternal fixation component1602 and secondexternal fixation component1604. Therough surfaces1618 and1628 can include serration or radial interdigitation or combinations thereof.
Theproximal frame connector1606 comprises an elongated body comprising a connectorproximal end portion1634 integrally formed with or coupled to apivot structure1636 having arough surface1638 and an opposingrough surface1640 and a through-bore connecting the two opposingsurfaces1638 and1640 bound by an inner surface configured (e.g. key ways1642) for receiving and locking onto at least a portion of thecartridge system1610, and a bifurcated connector distal end portion including a pair ofmovable portions1644 that are movable to flex toward and away from each other and arranged with one ormore protrusions1648 to engage with ahole1654 in adistal frame connector1650 of the lower frame such as thefoot frame1608.
The distal frame such as thefoot frame1608 comprises a ring frame configured to protect both the posterior and inferior aspects of a foot or the ankle. The ring frame comprises a multiple curved elongated body structure defining a first curved side rod spaced apart and parallel to a second curved side rod wherein a first end connector extending from said first curved side rod to said second curved side rod in said inferior portion and a second end connector extending from said first curved side rod to said second curved side rod in said posterior portion. Said inferior frame portion and said posterior frame portion are operatively disposed in at least partially surrounding and spatial relation to the ankle or the heel of thefoot36, wherein said posterior frame portion extends angularly from and above said inferior frame portion. Thefoot frame1608 has a curvature from inferior to posterior with its concave surface orienting toward the heel of the foot. Thefoot frame1608 further comprises adistal frame connector1650 with a through-bore extending longitudinally through at least a portion of theelongated body1650 for receiving the bifurcated connectordistal end portion 1644, and one ormore holes1654 for engaging with the one ormore protrusions1648 on the bifurcated connectordistal end portion1644. Theelongated body1650 is attached to a portion of one of the first and second curve side rods. The arrangement of themultiple holes1654 along thedistal frame connector1650 provides adjustability to the spatial relation between thefoot frame1608 and the heel or the ankle. The foot frame including the distal frame connector and the proximal frame connector can be formed as a unitary, prefabricated modular component (e.g. from multiple pieces welded together), a unitary component (e.g. from a single piece of material by molding), or a modular component (e.g. multiple pieces removably threaded together to allow surgeons to use as-is or to reconfigure to match the patient anatomy).
Thecartridge system1610 for coupling the system to a bone portion via abone pin600 or700 and locking thepivot structures1616, 1626, and1636, and thus, also locking the ankle-spanningexternal fixation system1600 comprises aknob1658, amain body1660, avariable position shaft1662 and aretaining clip1664.
Theknob1658 comprises aknob body1658a having a mainbody facing end1658b and anopposing end1658c. Theknob body1658a includes a funnel-like or frusto-conical internal surface or an internal surface having one or more tapered facets to receive and alternatively circumferentially compress and release a slit end or a funnel-like or tapered external surface of theshaft1662 for clamping a fixation element such asbone pin600. The funnel-like or frusto-conical internal surface or more generally the through-bore bound by walls extending from the mainbody facing end1658b to theopposing end1658c of theknob body1658a is designed to be larger toward the mainbody facing end1658b than toward the opposingend1658c of theknob body1658a, and includes a first locking feature such asthreads1658d. The tapered or conical internal surface inside theknob body1658a can be replaced with a taper insert. The opposingend1658c of theknob body1658a can include one or more slits or breakable lines for accommodating a broader range of dimensional tolerances of thebone pin600 or700. Theknob1658 can have irregularly shapedgeometry1666 for providing a secure grip surface and optionally a hexagonally shapedgeometry1668 that interfaces with a wrench.
The variable position shaft orshaft1662 includes an end portion including a stopper or an enlarged structure or structures such as ahead0016 for preventing theshaft1662 from passing completely through themain body1660, and a locking or engagement feature such asthreads1678 on the external surface of theshaft1662, and one or more breakable lines orslits1672 on an opposing end portion of the shaft. Theslit end1672 of theshaft1662 can be tapered to match the tapered internal surface of theknob body1658a. The funnel like or tapered internal surface of theknob body1658a preferably interacts via the engagement features, such as thethreads1658d and1678, with the externally tapered or funnel-like surface or theslit end1672 of theshaft1662 to provide clamping. The through-bore or opening in theopposing end1658c of theknob1658 has a diameter smaller than the uncompressed diameter of theslit end1672 of theshaft1662 to provide interference fit among the inner surface of theknob1658, theslit end1672 and the bone pin such asbone pin600 or700. Theshaft1662 is configured to extend through themain body1660 and into the through-bore of theknob1658 such that thestopper0016 is disposed in themain body1660 and at least a portion of thethreads1678 of theshaft1662 and theslit end1672 disposed outside themain body1660 and inside theknob body1658a. Theshaft threads1678 operably engage theinternal threads1658d of theknob1658 in forming a threaded connection with theknob1658 to form a cannulation or reception for receiving a bone pin, such asbone pin600, of uniform diameter, orbone pin700 of varying diameter. A portion of theshaft1662 or thestopper0016 can include an at least partially spherical surface to permit thebone pin600 or700 to orient relative to themain body1660, and can have at least one anti-rotation feature such asprotrusion1676 adapted to sit in a key way in themain body1660.
In operation, the tightening of theknob1658 pushes theslit end1672 of theshaft1662, guided by the tapered internal surface or structure of theknob body1658a, toward or through theopposing end1658c of theknob1658. Theslit end1672 is compressed circumferentially onto thebone pin600 or700 at theopposing end1658c of theknob1658 as theslit end1672 is pushed through the smaller opening at theopposing end1658c of theknob1658, and thus, clamping onto thebone pin600 or700 by interference fit.
Themain body1660 is configured to extend through thepivot structures1616, 1626, and1636 of the first and secondexternal fixation components1602 and1604 and theconnector1606. Themain body1660 has a cylindrical body withproximal protrusions1682 for engaging withkey ways1620 on the inner surface of thepivot structure1616 of the firstexternal fixation component1602 anddistal protrusions1684 for engaging withkey ways1630 on the inner surface of thepivot structure1626 of the secondexternal fixation component1604. Themain body1660 has inner surface configured to operably interact with theshaft1662 to provide both angular rotation of theshaft1662 relative to themain body1660 and anti-rotation of theshaft1662 during locking. The inner surface of the main body includes one or morekey way1686 for capturing theprotrusions1676 of theshaft1662 for rotational stability,concave surfaces1688 for interacting with the at least partiallyspherical stopper0016 of theshaft1662 and tapered orconical surface1690 for providing angular rotation of theshaft1662, and slottedgeometry1692 that accepts aring clip1664 for preventing thevariable position shaft1662 to exit themain body1660 once thecartridge system1610 is completely assembled.
The ankle-spanningexternal fixation system1600 is assembled by firstly, snap-fitting together the firstexternal fixation component1602, the secondexternal fixation component1604 and theconnector1606 via male/female ends on theirpivot structures1616, 1626 and1636. When the firstexternal fixation component1602, the secondexternal fixation component1604 and theconnector1606 are rotated into their closed state, thekey ways1620, 1630 and1642 of therespective pivot structures1616, 1626 and1636 become aligned and allow the assembledcartridge system1610 to slide in. Once thecartridge system1610 is in place, the firstexternal fixation component1602, the secondexternal fixation component1604 and theconnector1606 can be opened up to the desired position according to anatomical considerations. Once thecurrent embodiment1600 is deployed and in position, the cartridge system can be adjusted and then locked in place by further tighteningknob1658, which in turn locks the firstexternal fixation component1602, the secondexternal fixation component1604 and theconnector1606 via the interactions ofrough surfaces1618, 1638, 1640 and1628.
Referring now tofigures62-64, analternative embodiment1700 of the ankle-spanningexternal fixation system1600 is illustrated wherein thesystem1700 includes thecurved foot frame1706 comprising a U-shaped posterior (e.g., first) frame section and a U-shaped inferior (e.g., second) section connected at the base by a straight frame section. The two U-shaped frame sections are arranged to lie on different planes forming an angle of about 90 degrees. Other angles also lie within the spirit and scope of the various embodiments of the present invention.
Referring now tofigures65-69, analternative embodiment1800 of the ankle-spanningexternal fixation system1700 is illustrated wherein the firstexternal fixation component1802, secondexternal fixation component1804, and thefoot frame1810 are each of modular construction, comprising two or more straight and/or curved segments joined together via plug-socket joints and fixed in place by threading, snap-fitting or interference-fitting. Each of the firstexternal fixation component1802, secondexternal fixation component1804, and thefoot frame1810 of thesystem1800 can also be made into a unitary structure or unitary modular structure by molding or forming permanent connection among the subcomponents or segments by welding, soldering, crimping, brazing, and gluing/epoxying. Thesystem1800 can be single-use or disposable.
Referring now tofigure70, a flow diagram of an embodiment of amethod 3000 for fixating a bone fixator system about a target joint is shown. The method may be performed by a variety of users, including healthcare professionals, technicians, and patients installing and/or adjusting the bone fixator system. The bone fixator system used to implement the method may be or include features of any of the fixation systems disclosed herein (e.g.,external fixation systems 100, 200, 800, 900, 1000, 1100, 1200, 1400, 1500, 1600, 1700, 1800, etc.) and the clamping devices used herein to implement the method may be or include features of any of the clamping devices and systems disclosed herein (e.g.,clamp systems 300, 400, 500, 1300, 2600, etc.).
At 3010, components of a bone fixator system are aligned with target bone(s) about a target joint to be fixated. The target joint may be an elbow, a knee, an ankle, etc. For example, the bone fixator system may include a first fixation component and a second fixation component, the first fixation component may be aligned relative to a first target bone disposed adjacent to the target joint, and the second fixation component may be aligned relative to a second target bone disposed adjacent to the target joint on another side of the knee from the first target bone.
A clamp is also aligned relative to a target bone. For example, a clamp may be aligned with the target bone based on a desired position and/or orientation of a bone pin to be attached to the bone and secured or otherwise received by the clamp. The clamp may also be received on one of the fixation components of the bone fixator system while aligning the clamp.
At 3012, a bone pin is attached (e.g., secured, coupled, drilled in, etc.) to a target bone using a clamp as a drill guide. For example, the clamp may define a through-bore configured to receive the bone pin. The through-bore may be used to sight or otherwise identify a target position on a surface of the target bone at which the bone pin is to be attached to the target bone. The bone pin is received through the through-bore of the clamp, and may be drilled into the bone. The clamp may be locked about the bone pin.
At 3014, the clamp is locked to the bone fixation component. For example, the clamp may include a pair of jaws defining an aperture through which the bone fixation component may pass, and a locking device may be used to force the jaws to compress the bone fixation component in order to lock the clamp to the bone fixation component.
At 3016, it is determined whether the bone fixation system is disposed in a desired orientation (e.g., position and/or angle relative to target joint, target bones, etc.). If the bone fixation system is not disposed in a desired orientation (e.g., the orientation is not acceptable), then at 3018, clamp(s) may be unlocked, providing degrees of freedom allowing for adjustment of the bone fixation system and components of the bone fixation system.
In some embodiments, determining whether the bone fixation system is disposed in a desired orientation includes comparing an observed joint status of the target joint to a desired joint status of the target joint. For example, a clinical goal for the joint may include a particular joint status (e.g., a degree of flexure of the joint, relative angles of the bones about the joint, etc.) to be achieved using the bone fixation system.
If it is determined that the bone fixation is disposed in a desired orientation, then at 3020, it is determined whether an additional bone pin needs to be attached. If it is determined that an additional bone pin is needed, then the procedure outlined insteps 3010, 3012, 3014, 3016, and 3018 may be followed to provide an additional clamp and attach an additional bone pin.
If it is determined that an additional bone pin is not needed, then at 3022, angle(s) between various components in the bone fixation system, such as between a first fixation component and a second fixation component, may be adjusted.
At 3024, after adjusting angles of the bone fixation system, it is determined whether the bone fixation system is disposed in a desired orientation. If it is determined that the bone fixation system is not disposed in a desired orientation, then at 3026, any locked clamp(s) and bone fixation component(s) are unlocked, allowing for adjustment of the orientation of the bone fixation system, such as by adjusting angle(s) between bone fixation components. An angle of a clamp relative to a bone fixation component may be adjusted, such as by adjusting an angle defined by a longitudinal axis of the bone fixation component and a plane transverse to a through-bore of the clamp in which the bone fixation component is received. A position of the clamp relative to the bone fixation component may be adjusted as well, such as by shifting and/or sliding the bone fixation component and the clamp relative to one another.
In some embodiments, the bone fixation system is configured to be fixated about a target ankle joint. The bone fixation system includes a first frame which may be aligned about a first target bone of the lower extremity adjacent to the target ankle joint. The bone fixation system also includes a second frame which may be aligned to at least partially surround the target ankle. For example, the second frame may include an inferior frame portion and a posterior frame portion. Fixating such a bone fixation system may include aligning the first frame with a first target bone of the lower extremity, aligning the second frame such that the inferior frame is disposed in an inferior position relative to the target ankle joint and such that the posterior frame is disposed in a posterior position relative to the target ankle joint, aligning a first clamp with the first target bone, attaching a first bone pin to the first target bone using the first clamp as a drill guide, and locking the first clamp to the first frame. In some embodiments, such a bone fixation system may be further fixated by aligning a second clamp with a second target bone (e.g., a bone of the foot or of the heel), attaching a second bone pin to the second target bone using the second clamp as a drill guide, and locking the second clamp to the second frame.
If it is determined that the bone fixation system is disposed in a desired orientation, then at 3028, all clamp(s) and bone fixation component(s) are locked. For example, locking devices may be used to lock clamp(s) to respective bone fixation component(s). In some embodiments, bone fixation components may be engaged and locked using fasteners or other engagement devices as disclosed herein.
The principles, preferred embodiments and modes of operation of the present invention have been made apparent in the foregoing description.
Although the embodiments are numbered with, for example, "first," "second," or "third," or "fourth," the ordinal numbers do not imply priorities of the embodiments.
Since many modifications, variations and changes in detail can be made to the described embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims.

Claims

A clamping device (400) for an external fixation system, comprising:
a clamp body (402) and a locking assembly (404, 406), the clamp body including a first jaw (402a) and a second jaw (402b), the first jaw (402a) and second jaw (402b) defining a slot (410) extending between a first surface of the first jaw and a second surface of the second jaw and in communication with a first channel (402c), the first channel (402c) configured to accommodate a first fixation element along a first longitudinal axis of the first channel (402c), the first jaw (402a) defining a first opening and the second jaw (402b) defining a second opening that are sized to receive a portion of the locking assembly (404, 406), the first opening and the second opening defining a second longitudinal axis passing through the first opening and the second opening;
the locking assembly including a first fastening element (406) configured to pass through the first opening and the second opening when a third longitudinal axis of the first fastening element (406) is aligned with the second longitudinal axis, the first fastening element (406) defining a second channel configured to accommodate a bone pin for insertion into a bone of a subject,
the locking assembly including a second fastening element (404) configured to engage with the first fastening element (406), wherein the locking assembly is configured to restrict movement of the first fixation element relative to the clamp body (402) and restrict movement of the bone pin (600) relative to the clamp body (402) in response to tightening of the locking assembly (404, 406);
wherein the second jaw (402b) further defines at least one recess of the second opening and the first fastening element (406) includes at least one protrusion (420), the at least one recess (448) configured to:
(1) receive the at least one protrusion (420) to prevent rotation of the first fastening element (406) relative to the second jaw (402b); and
(2) prevent the at least one protrusion (420) from being received by the at least one recess when the at least one protrusion (420) is not aligned with the at least one recess.
The clamping device of claim 1, wherein the first channel is defined by a first recess of the first surface, a second recess of the second surface, and a gap extending from a first edge of the first recess to a second edge of the second recess, the gap disposed on an opposite side of the first channel from the slot.
The clamping device of claim 1, wherein the first channel is defined by a first recess of the first surface, a second recess of the second surface, and a third surface connecting the first recess to the second recess.
The clamping device of claim 1, wherein the first jaw further includes an annular protrusion defining a portion of the first opening, and the second fastening element includes a first engagement feature configured to lock angularly with the annular protrusion in response to tightening of the locking assembly.
The clamping device of claim 4, wherein the first engagement feature includes one of radial interdigitation or serration.
The clamping device of claim 1, wherein the first fastening element includes a threaded shaft configured to threadingly engage an inner surface of the second fastening element in response to tightening of the locking assembly.
The clamping device of claim 1, wherein the first fastening element defines a slit extending into the second channel, the slit configured to compress against the bone pin in response to tightening of the locking assembly.
The clamping device of claim 1, wherein the first jaw and the second jaw each include one of radial interdigitation or serration facing into the first channel to frictionally engage the first fixation element.
The clamping device of claim 1, wherein the first fastening element includes a first tapered shape configured to match a second tapered shape of the second fastening element such that an outer surface of the first fastening element is configured to contact along an inner surface of the second fastening element in response to tightening of the locking assembly.
The clamping device of claim 1, wherein the second opening includes a first diameter proximate to the slot and a second diameter distal from the slot, the second diameter greater than the first diameter, the first diameter configured to secure a stopper of the first fastening element in the second opening and prevent the stopper from passing through the second opening.
The clamping device of claim 1, further comprising a first insert configured to define a portion of the first opening and be inserted into a recess defined in a third surface of the first jaw opposite the first surface of the first jaw, a second insert configured to define a portion of the second opening and be inserted into a recess defined in a fourth surface of the second jaw opposite the second surface of the second jaw, and a third insert shaped to conform to the first surface, the second surface, and the first channel and configured to modify a space between the first jaw and the second jaw, the second fastening element including a first engagement feature configured to lock angularly with the first insert in response to tightening of the locking assembly.